Sr Prin Regulatory Affairs Specialist

Medtronic • Mounds View, MN

2d

About The Position

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. A Day in the Life The Senior Principal Regulatory Affairs Specialist will play a key role in creating regulatory strategies and submissions to bring new robotic products to the global markets. This role will also work on new product development, as well as work on sustaining/post-market regulatory activities for Class II robotic devices. Devices that are part of the Robotics Surgical Technology Business are inclusive of hardware and software components. The senior principal specialist will work directly with new product development and sustaining teams to develop the global regulatory strategy and support regulatory activities throughout the product lifecycle. The senior principal specialist has primary responsibility for compliance with US and EU regulatory requirements and partners with the international regulatory affairs group to support regulatory submissions worldwide for Class II medical devices. This includes support of product changes to ensure that regulatory requirements continue to be met, documenting regulatory decisions, submissions to agencies, reviewing promotional materials, and ensuring that product technical documentation is current and accurate. Responsibilities are performed through the collaboration with various functions across the business unit, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing. Responsibilities also include keeping senior management informed of the regulatory status of products and significant regulatory issues and maintaining proficiency in global regulatory requirements. The successful candidate will be able to deal with advanced concepts and undefined paths, work independently, develop new and creative regulatory strategies and work collaboratively within the Regulatory department and other business functions. Responsibilities may include the following and other duties may be assigned.

Requirements

• Bachelor’s degree required
• Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.

Nice To Haves

• Degree in Engineering
• Experience with US and EU submissions (e.g. 510(k), PMA, Pre-Sub, PCCP, IDE, MDR, etc.) with complex medical device systems including hardware, software and artificial intelligence
• Demonstrated ability for strategic thinking, project planning
• Strong influence skills. Demonstrated ability to work cooperatively at all levels in an organization to build and maintain relationships required to accomplish program goals
• Ability to balance priorities, work independently or collaboratively to determine and develop solutions
• Excellent verbal/ written communication and presentation skills. Demonstrated ability to succinctly and accurately communicate to various cross functional partners.
• For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.

Responsibilities

• Develop and support global regulatory strategies for Class II devices and accessories for robotic surgical application.
• Be an active member of the product development core teams and responsible for identifying submission deliverables, timelines, and strategic direction.
• Reviews and approves technical documentation.
• Provide feedback and work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies and provide ongoing support to product development teams to assure timely resolution to regulatory issues and questions.
• Prepare FDA IDE submissions, DeNovo/510(k) submissions, or EU submissions for new products and product changes as required.
• Directly communicates with regulatory authorities to resolve questions/issues that arise prior to and during product submissions or other pertinent issues.
• Participate in the product change assessments and define the regulatory impact of product changes in global markets.
• Provide support to market released products as necessary. This includes reviewing labeling, product changes, and documentation for changes requiring regulatory approval.
• Keeps abreast of new and changing global regulatory requirements and keep the business informed of implications of changes
• Collaborate with International regulatory teams to understand worldwide regulatory requirements to enable the development of strategies and requirements for global commercialization.
• Interact directly with major market regulatory agencies in support of product registration, approval, and commercialization.
• Leads or performs coordination and preparation of document packages for global regulatory submissions, license renewals, internal & external audits and inspections.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Plays an active role in continuous improvement of regulatory processes for the Robotics Business Unit.

Benefits

• Medtronic offers a competitive Salary and flexible Benefits Package
• We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
• Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
• Incentive plans, 401(k) plan plus employer contribution and match, Short-term disability, Paid time off, Paid holidays, Employee Stock Purchase Plan, Employee Assistance Program, Non-qualified Retirement Plan Supplement (subject to IRS earning minimums), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees